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Walking and Balance Post-TBI

IMPROVING WALKING AND BALANCE IN VETERANS WITH TRAUMATIC BRAIN INJURY: A PILOT STUDY EXAMINING FEASIBILITY AND DOSAGE

This is a case series study evaluating the feasibility and dosage of Intensive Mobility Training (IMT). Twelve participants with chronic, mild-to-moderate, Traumatic Brain Injury (TBI) causing significant locomotor impairment, who meet these specific criteria, will be recruited. Location and nature of neural insult will be determined by multimodal Magnetic Resonance Imaging (MRI) exam. All participants will receive 3 hours of rehabilitation per day for 20 days, focusing on gait and balance. Locomotion and balance will be comprehensively tested prior to IMT, after 10 days of IMT, and then again after the full dose of IMT. This study will determine the feasibility of this intervention in the population of TBI patients, allow an estimate of effect size and provide initial information on possible neural predictors of success. Furthermore the investigators will be able to determine whether the dosage of 10 days is sufficient or whether significant improvements are made with 20 days of the intervention.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

11

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • South Carolina
      • Columbia, South Carolina, Estados Unidos, 29208
        • 921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. greater than 3 months post-TBI (as defined by INTRuST criteria) and no longer receiving care as an inpatient in a rehabilitation facility.
  2. the ability to follow simple three-step commands;
  3. the ability to communicate presence and location of pain;
  4. the ability to sit independently without back or arm support for five minutes;
  5. the ability to stand with support of a straight cane, quad cane, or walker for 2 minutes;
  6. the ability to walk 10 meters with maximum 1 person assisting;
  7. presence of motor deficits (determined by clinical assessment of paresis);
  8. age ≥ 18;
  9. ability to give consent or have a acceptable surrogate capable of giving consent on subject's behalf

Exclusion Criteria:

  1. unable to ambulate 500 feet prior to TBI;
  2. history of serious chronic obstructive pulmonary disease or oxygen dependence;
  3. severe weight bearing pain;
  4. lower-extremity amputation;
  5. non-healing ulcers on the lower-extremity;
  6. renal dialysis or end stage liver disease;
  7. legal blindness or severe visual impairment;
  8. severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10°, knee flexion Range of Motion < 90°, hip flexion contracture > 25°, and ankle plantar flexion contracture > 15°);
  9. history of deep venous thrombosis or pulmonary embolism within 6 months
  10. uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
  11. severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest;
  12. intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded);
  13. history of severe uncontrolled seizure disorder;
  14. other neurological conditions such as multiple sclerosis or Parkinson's Disease;
  15. pain that is scored greater than 5 out of 10 on a visual analog scale;
  16. any factor contraindicative to MRI examination (e.g., cardiac pacemaker/ defibrillator, pregnancy, aneurysm clips, insulin pump, metal fragments in the body).
  17. any other health problems judged by their screening physician to put the client at significant risk of harm during the study

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intensive Mobility Training (IMT)
Intensive Mobility Training will be used as an intensive physical therapy intervention. Participants will receive 3 hours per day for a 10 day session, be post-tested, and receive another 10 day session followed by two more testing sessions.
Intensive Mobility Training will be used as an intensive physical therapy intervention. Participants will receive 3 hours per day for a 10 day session, be post-tested, and receive another 10 day session followed by two more testing sessions.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility as measured by study completion.
Periodo de tiempo: post-treatment (after 20-day intervention)
Feasibility will be determined by the ratio of participants that complete the intervention.
post-treatment (after 20-day intervention)
Feasibility as measured by pain ratings.
Periodo de tiempo: during 20-day intervention
Feasibility will be determined by daily change in pain scores as measured using visual analog scales.
during 20-day intervention
Feasibility as measured by fatigue ratings.
Periodo de tiempo: during 20-day intervention
Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.
during 20-day intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Efficacy as measured by improvements in gait and mobility.
Periodo de tiempo: from pre- to post-treatment during 20-day intervention.
Efficacy will be measured by improvements in mobility and gait as measured by the Dynamic Gait Index, Timed Up and Go, Six- Minute Walk, and Falls Efficacy Scale.
from pre- to post-treatment during 20-day intervention.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Stacy Fritz, Ph.D., P.T., University of South Carolina

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2011

Finalización primaria (Actual)

1 de marzo de 2013

Finalización del estudio (Actual)

1 de marzo de 2013

Fechas de registro del estudio

Enviado por primera vez

16 de agosto de 2011

Primero enviado que cumplió con los criterios de control de calidad

16 de agosto de 2011

Publicado por primera vez (Estimar)

17 de agosto de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

26 de abril de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

25 de abril de 2013

Última verificación

1 de abril de 2013

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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